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Specialist in validation and certification
The production protocol analyst.
The specialist in validation and certification advises on the standards (Good Manufacturing Practices or GMP for example), the procedures and the regulations that should be taken into account in production. He designates the necessary equipment, the components and the services that may be used. He writes up and verifies reference documentation and assesses procedures. He contributes to audits (internal and external) and to quality support. Although he does not participate directly in production, he is “at the helm” and others follow his directions.
The specialist in validation works in the quality department in the chemical or biopharmaceutical industry. He may also be found in the food industry, in hospitals or in cosmetics. He works closely with lab technicians and production technicians.
Skills required: conscientiousness — organisation and precision — analysis and ability to see the big picture — logical and methodical — patience and perseverance